1. Field of the invention
This invention relates to a concentrated hormone pharmaceutical composition to be used in the production of hormone replacement therapies.
2. Description of the related art
Natural Hormone Replacement Therapy has been around for more than twenty years. The term “natural” comes from the fact that the hormones (estrogens such as estradiol, estrone, and estriol, testosterone, DHEA, pregnenolone and progesterone) come from natural sources. However, more importantly, the term means that the hormones have the exact same molecular structure as those produced by the body itself, thus the body recognizes the hormones as being “natural”, because they are “bio-identical”, therefore, the shift to a more appropriate name, Bio-identical Hormone Replacement Therapy (BHRT).
Some of the benefits of BHRT include: fewer side effects compared with traditional HRT; protection against heart disease, reduced risk of breast cancer, and improved lipid profile.
Bio-identical Hormone Replacement Therapy products are compounded by a compounding pharmacist, which offers you and your physician a choice for individualized hormone replacement. Generally the BHRT pharmaceutical compositions are sold in the form of ointments, creams, gels, pastes, capsules, troches, lozenges, lollipops, tablet triturates, sublingual tablets, and tablets.
A BHRT ointment, cream, gel, or paste may include, but is not limited to, the active hormone or hormones, a suitable solvent or solvents, including, but not limited to, ethoxy diglycol, propylene glycol, alcohol, or glycerin and any suitable ointment, cream, or gel base which allows for transdermal absorption of bio-identical hormones.
Producing BHRT pharmaceutical compositions is a very lucrative business for compounding pharmacies. However, the process of producing the BHRT pharmaceutical compositions is an extremely time-consuming process and has many risks and subsequent costs associated with the compounding of BHRT pharmaceutical compositions.
One of the main problems with compounding BHRT pharmaceutical compositions is the substantial risk of employee contamination (inhalation or transdermal absorption of the hormones) with the hormones. The hormones used for producing the BHRT pharmaceutical compositions are naturally found in the body in physiological levels. Thus, when a human is chronically exposed to higher than normal levels of these hormones, they are at risk of developing serious adverse medical effects, including, but not limited to, an unnatural increased response by each system of the body which is affected by each individual hormone, as well as an increased risk of developing numerous varieties of cancer.
In addition, producing these BHRT pharmaceutical compositions requires great skill and knowledge. It also requires expensive equipment such as accurate electronic scales, electronic mortars and pestles (EMP), and ointment mills.
In order to diminish these risks, the compounding pharmacies have developed an expensive and time-consuming method to reduce employee exposure to these hormones. These measures include, but are not limited to, the use of a custom built clean room, high velocity air flow units fitted with high emission particulate air (HEPA) filters, custom built ventilation systems, protective suits, protective eyewear, protective gloves, and protective HEPA filter masks.
The production of BHRT pharmaceutical compositions is by itself a time-consuming process. Each ointment, cream, gel, or paste must be specifically engineered for each patient based on his or her distinct hormone profile, thus the use of bulk compounding is precluded, because each medication is produced custom fit for each patient.
Furthermore, bulk compounding or manufacturing of hormone products is illegal in most states without a proper license.
In order to produce these BHRT pharmaceutical compositions safely and accurately, compounding pharmacies need to invest a great deal of time and money into these safety measures. The pharmacies would also need to employ a specially trained staff; all these measures decrease productivity substantially.
These measures are not only expensive, but also create an unpleasant work environment. This is due to the fact that the employee is covered from head to toe in restrictive, uncomfortable protective gear. They are also working in a room, which is noisy because of the high velocity ventilation systems, which are in constant use.
In order to work with BHRT pharmaceutical compositions, an employee must:                Be trained in the art of compounding BHRT ointments, creams, gels, and pastes.        Ensure they are wearing all the necessary protective gear.        Locate all of the ingredients.        Weigh all of the ingredients in the appropriate environment, a clean room with proper ventilation and filtration systems, to prevent exposure to harmful chemicals.        Combine the ingredients using the EMP to ensure thorough mixing. If the mixture is not thoroughly mixed, then it will not contain a uniform concentration of the drug throughout.        Run the mixture through an ointment mill to decrease the particle size of the drug. This will increase absorbability, as smaller drug particles will more readily penetrate the dermis. This process also ensures a non-gritty, pharmaceutically elegant, and cosmetically pleasing final product.        
The combination of the potential risks associated with producing BHRT pharmaceutical compositions, specially trained employees to compound these compositions safely and accurately, purchasing all the necessary equipment and safety measures, and the actual time required to compound each individual pharmaceutical composition result in an extremely time-consuming, hazardous, and expensive process.
The present inventor thought of the necessity of providing pharmacies with a system that is easy to use and saves time and money for those pharmacies dealing with BHRT pharmaceutical products while decreasing risk and increasing product quality.